On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic®...
Approval Alert: FDA Approves Alvotech & Teva’s Ustekinumab, Selarsdi™
On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to...
New Indication Alert: MSD’s Keytruda® Obtains Approval for Cervical Cancer Indication in Korea
The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained...
Fresenius Launches Biosimilar Tocilizumab in the US
On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra®...
Celltrion Presents Phase 3 Results for Denosumab Biosimilar
The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to...
Aflibercept Appeals Dismissed for Lack of Jurisdiction
As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for...
Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia
On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement...
Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar
On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17),...
Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland
On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab) biosimilar FYB201 in...
Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)
On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for...
Ginkgo Bioworks to Improve Novo Nordisk’s Chronic Disease Medications Manufacturing Over 5 Years
Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader,...
Genentech & Dr Reddy’s Settle US Rituximab Dispute
On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New...
Samsung Bioepis Releases Fifth Biosimilar Market Report: Adalimumab Biosimilar Uptake at 4% Following First Year of Biosimilar Competition
On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report. The quarterly report details average...
Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar
On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Xgeva®) received...
Samsung Bioepis Commences Phase 3 Trials for Keytruda® Biosimilar
On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s...
Shanghai Henlius’ Ph 3 success for Prolia® biosimilar HLX14 (denosumab)
On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is...